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临床试验/NCT07170930
NCT07170930Enrolling By Invitation不适用

The Effect of a Training Programme in the Variation of Fitness Parameters, Physiological, Hematological and Biochemical Indicators of Soccer Players During the Preseason Period

Emmanouil D. Zacharakis1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
24
试验地点
1
主要终点
Testosterone

研究概览

简要总结

The goal of this study is to investigate the effects of varying friendly match-play exposure during the late pre-season on physiological, biochemical, and performance adaptations in soccer players. It is hypothesized that (i) significant changes will occur across the pre-season in both the extended- and limited-play groups when analysed independently; (ii) distinct group-specific adaptations will emerge by the end of the preparatory period; and (iii) match-play exposure, when analysed across all participants, will be significantly correlated with physiological and performance outcomes at pre-season completion. Players from a randomly selected team will be assessed at three time points: pre-season start, mid-pre-season (MPS), and pre-competition phase (PC). Assessments will include anthropometry, physical performance, and markers of muscle damage, inflammation, hormonal status, and haematology. Based on the total match-play time of 8 friendly games during the late pre-season, players will be retrospectively categorised into extended-play (EP) and limited-play (LP) cohorts.time of 8 friendly games during the late pre-season, players will be retrospectively categorised into extended-play (EP) and limited-play (LP) cohorts.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Male participants
  • Aged 18 years or older
  • Non-smokers
  • Injury-free for the past 6 months
  • Medication-free for the past 6 months
  • Abstinent from alcohol
  • Living at an altitude below 1500 meters
  • Committed exclusively to soccer (no participation in other sports)

排除标准

  • History of serious injuries (e.g., fractures, ligament tears) within the past 6 months
  • Chronic medical conditions such as cardiovascular disease, diabetes, or respiratory disorders
  • Current use of performance-enhancing drugs or supplements
  • Participation in non-soccer-related sports or activities during the study period

结局指标

主要结局

Testosterone

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Serum testosterone measured to assess hormonal adaptations. Unit of Measure: ng/dL

C-Reactive Protein (CRP)

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: CRP measured as a marker of systemic inflammation. Unit of Measure: mg/L

Cortisol

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Serum cortisol measured to monitor stress response. Unit of Measure: µg/dL

High-sensitivity CRP (hs-CRP)

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: hs-CRP measured to detect low-grade inflammation. Unit of Measure: mg/L

Interleukin-6 (IL-6)

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: IL-6 measured from serum to assess inflammatory response. Unit of Measure: pg/mL

Testosterone-Cortisol Ratio

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Calculated ratio to estimate anabolic-catabolic balance. Unit of Measure: Ratio

Body Mass

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Body mass measured at standard anatomical sites using a calibrated scale to track longitudinal changes over the pre-season. Unit of Measure: kg

Body Fat

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Body fat percentage measured using skinfold calipers at standard sites to monitor longitudinal changes. Unit of Measure: %

Rate of Perceived Exertion (RPE)

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Participants rate exertion during standardized training sessions using the Borg Scale (6 = no exertion, 20 = maximal exertion). Unit of Measure: Borg 6-20 scale

Glucose

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Fasting blood glucose measured to track metabolic changes over pre-season. Unit of Measure: mg/dL

Cholesterol

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Total serum cholesterol measured to assess lipid profile adaptations. Unit of Measure: mg/dL

Triglycerides

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Serum triglycerides measured to monitor metabolic response to training. Unit of Measure: mg/dL

SGOT (AST)

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Serum glutamic-oxaloacetic transaminase measured to assess liver/muscle stress. Unit of Measure: U/L

SGPT (ALT)

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Serum glutamic-pyruvic transaminase measured to monitor liver/muscle stress. Unit of Measure: U/L

Creatine Phosphokinase (CPK)

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: CPK measured to detect skeletal muscle damage. Unit of Measure: U/L

Myoglobin

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Myoglobin measured as a marker of muscle damage. Unit of Measure: ng/mL

Iron

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Serum iron measured to assess iron status. Unit of Measure: µg/dL

Ferritin

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Serum ferritin measured to monitor iron storage. Unit of Measure: ng/mL

Tumor Necrosis Factor-alpha (TNF-α)

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: TNF-α measured as a marker of systemic inflammation. Unit of Measure: pg/mL

Red Blood Cells (RBC)

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: RBC count measured from blood to assess oxygen transport capacity. Unit of Measure: million cells/µL

Hemoglobin

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Hemoglobin measured to evaluate oxygen-carrying capacity. Unit of Measure: g/dL

Hematocrit

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Hematocrit measured as percentage of RBC in blood. Unit of Measure: %

White Blood Cells (WBC)

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: WBC count measured to monitor immune function. Unit of Measure: cells/µL

Platelets

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Platelet count measured to assess hematological health. Unit of Measure: cells/µL

Countermovement Jump Height

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Jump height measured (cm) to assess lower-limb explosive power. Unit of Measure: cm

Knee Extensor Power, Dominant Leg

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Measured using isokinetic dynamometer. Unit of Measure: Watts

Knee Extensor Power, Non-Dominant Leg

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Measured using isokinetic dynamometer. Unit of Measure: Watts

Knee Flexor Power, Dominant Leg

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Measured using isokinetic dynamometer. Unit of Measure: Watts

Knee Flexor Power, Non-Dominant Leg

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Measured using isokinetic dynamometer. Unit of Measure: Watts

10-m Sprint Time

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Sprint time measured using photocell gates; lower times indicate better performance. Unit of Measure: seconds

T-Test Agility

时间窗: Each measure assessed at Baseline (pre-season start), 4 weeks (mid-pre-season), and 8 weeks (pre-competition phase).

Description: Participants perform T-test agility course; lower times indicate better agility. Unit of Measure: seconds

次要结局

未报告次要终点

研究者

发起方
Emmanouil D. Zacharakis
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Emmanouil D. Zacharakis

PhD

National and Kapodistrian University of Athens

研究点 (1)

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